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AveloxAvelox

NAME OF THE MEDICINAL PRODUCT

Avelox 400 mg film-coated tablets Avelox 400 mg solution for infusion


QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE SUBSTANCE(S)

1 film-coated tablet contains 436.8 mg moxifloxacin hydrochloride, equivalent to 400 mg moxifloxacin.
250 ml solution for infusion contain 436.8 mg moxifloxacin hydrochloride, equivalent to 400 mg moxifloxacin.


PHARMACEUTICAL FORM

Film-coated tablet Solution for infusion


INDICATIONS
Avelox tablets are indicated for the treatment of adults (≥ 18 years of age) with the following bacterial infections caused by susceptible strains:
Acute sinusitis
Acute exacerbations of chronic bronchitis
Community acquired pneumonia
Complicated skin and skin structure infections
Complicated intra-abdominal infections including polymicrobial infections such as abscesses


Avelox solution for infusion is indicated for the treatment of adults (≥ 18 years of age) with the following bacterial infections caused by susceptible strains:
Community acquired pneumonia
Complicated skin and skin structure infections
Complicated intraabdominal infections including polymicrobial infections such as abscesses Consideration should be given to official guidance on the appropriate use of antibacterial agents.


DOSAGE AND METHOD OF ADMINISTRATION
Dose (adults)
The recommended dose for moxifloxacin is 400 mg once daily (1 film-coated tablet resp. 250 ml solution for infusion) for the above mentioned indications and should not be exceeded.


Duration of treatment
The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations for the treatment of upper and lower respiratory tract infections are made:


Film-coated tablet:
Bronchitis: acute exacerbation of chronic bronchitis, 5 days.
Pneumonia: community acquired pneumonia, 10 days.
Sinusitis: acute sinusitis, 7 days.
Complicated skin and skin structure infections total treatment duration for sequential therapy (intravenous followed by oral therapy): 7-21 days.
Complicated intraabdominal infections total treatment duration for sequential therapy (intravenous followed by oral therapy): 5 -14 days.


Solution for infusion:
Therapy may be initial intravenous administration, followed by oral administration of film-coated tablets when clinically indicated.
Pneumonia: community acquired pneumonia: The recommended total treatment duration for sequential administration (intravenous followed by oral therapy) is: 7-14 days.
Complicated skin and skin structure infections total treatment duration for sequential therapy (intravenous followed by oral therapy): 7 - 21 days.
Complicated intraabdominal infections total treatment duration for sequential therapy (intravenous followed by oral therapy): 5 - 14 days.


The recommended duration of treatment for the indication being treated should not be exceeded.


Moxifloxacin 400 mg film-coated tablets and Moxifloxacin 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).


Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with Avelox may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.


To reduce the development of drug-resistant bacteria and maintain the effectiveness of Avelox and other antibacterial drugs, Avelox should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

 

Method of administration
The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals. The solution for infusion should be infused intravenously over 60 minutes.


A statement "Infuse over a period of 60 minutes" should be given on the primary packaging material of the infusion solution.


The solution for infusion can be administered directly or via a T -tube together with compatible infusion solutions. The following coinfusions were found to form stable mixtures over a period of 24 hours at room temperature with moxifloxacin solution for infusion, and can therefore be considered as compatible with moxifloxacin solution for infusion:


Water for Injections

Sodium Chloride 0.9%

Sodium Chloride 1 molar

Glucose 5%

Glucose 10%

Glucose 40%

Xylitol 20%
Ringer's Solution
Lactated Ringer's Solution


If moxifloxacin solution for infusion is to be given with another drug, each drug should be given separately (see also Pharmaceutical Particulars, Incompatibilities).


Only clear solutions are to be used.


Elderly
No adjustment of dosage is required in the elderly.


Children
Efficacy and safety of moxifloxacin in children and adolescents have not been established (see also Contraindications).


Interethnic differences
No adjustment of dosage is required in ethnic groups.


Hepatic Impairment
No dosage adjustment is required in patients with impaired liver function (see also Special Warnings and Precautions for use in patients with liver cirrhosis).


Renal Impairment
No dose adjustment is required in patients with renal impairment (including creatinine clearance ≤ 30 ml/min/1.73m2) and in patients on chronic dialysis i.e. hemodialysis and continuous ambulatory peritoneal dialysis.
 

CONTRAINDICATIONS
Known hypersensitivity to any component of Moxifloxacin or other quinolones or any of the excipients.

Pregnancy and lactation.
Patients below 18 years of age.
 

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